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Absolute and relative tumour uptake and retention of fluciclatide [ Time Frame: Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment ]

• Progression free survival at 12 months- defined as time from last study scan to the date of disease progression or death due to the disease, whichever occurs first [ Time Frame: 12 months after the final reseach scan. ]

Overall survival at 12 months [ Time Frame: 12 months after the final reseach scan. ]

safety profile [ Time Frame: within 12 months of the last research scan ]

Number of participants with adverse events attributed to the 18F-RDG-PET imaging agent (CTCAE Criteria)

Fluciclatide (GE Healthcare) (AH111585) is a small cyclic peptide containing the RGD tripeptide (figure 1), which preferentially binds with high affinity to α¬vβ3 integrins that are up-regulated in angiogenesis.

The IMP is supplied as a solution for injection, 400 MBq at the reference date and time. Participants will receive one injection of the imaging agent at this dose on 3 occasions

Other Name: αvβ3 Integrin Imaging with Fluciclatide (AH111585)

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients should have advanced or metastatic RCC confirmed by histological diagnosis

Patients considered suitable for therapy with TKI for RCC according to responsible clinician

Measurable tumour according to RECIST v1.1 criteria

Standard staging CT scan performed within 28 days of first research scan

The patient has not received chemotherapy, radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to recruitment

Age ≥18 years

Adequate renal function (creatinine <1.25xULN)

Patient is able to tolerate and comply with scanning procedure

Patient is not lactating or pregnant

Absence of any psychological, familial, sociological or geographical condition which in the opinion of the Investigator may potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Able and willing to give informed consent

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492192